Patient-focused drug development: New FDA draft guidance delves into what’s important
The FDA on Monday published the second in a series of four guidance documents on patient-focused drug development, with this latest draft helping sponsors identify what is most important to patients with respect to their experience with disease burden and treatment.
In determining what’s important, the FDA recommends that sponsors use qualitative research methods, which can generate in-depth thoughts from patients in their own words through interviews or focus groups, quantitative research methods, which can use statistical methods to summarize the collective patient experience data, or mixed-methods research, which can combine qualitative and quantitative methods to understand the patient experience.
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